FDA UDI Not in Commercial Distribution 🇺🇸 United States

cobas u 411 Urine Analyzer

DI: 04015630925636 · Model: 4906969001 · Roche Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
cobas u 411 Urine Analyzer
Primary DI
04015630925636
Version / Model
4906969001
Catalog Number
4906969001
Company Name
Roche Diagnostics GmbH
Labeler DUNS
315028860
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-20
Public Version
4
Public Version Date
2022-09-16
Public Version Status
Update
Public Device Record Key
ae57a7f4-5b97-4646-8625-cead1e386b2f
Distribution End Date
2018-07-02

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KQO AUTOMATED URINALYSIS SYSTEM

GMDN Terms

Code Name
35918 Urine analyser IVD, laboratory

Identifiers

Type ID
Primary 04015630925636